Shelf Life:

4 years

Specification:

BP

Test Items

Specification

Results of Analysis

Appearance

Yellow crystalline powder

Complies

Solubility

Freely soluble in water, sparingly soluble in ethanol, solutions in water   become turbid on standing, owing to the precipitation of Oxytetracycline.

Complies

Identification

According to BP2011

Complies

Tests

pH

2.3-2.9 

2.5

Absorbance

270-290

271

Specific optical rotation

-188° to -200°

-190°

Heavy metals

Not more than 50

Complies

Light absorbing impurities

Absorbance at 430nm shall not be more than 0.50

0.32

Absorbance at 490nm shall not be more than 0.20

0.1

Related substances

content of impurity peak meets the requirements

Complies

Sulphatd ash

Not more than 0.5%

0.09%

Water

Not more than 2.0%

1.2%

HPLC Assay

95.0%-102.0%

96.1%